Lecture No.5 : Risk Assessment of Pharmaceutical Waste Production Distribution Disposal

Content of Presentation - Life Cycle Review of Environmental and Health Impacts - Risk management in Life Cycle Stages - Risk management of substances used in Pharmaceuticals

- Package description should advice on disposal “ Unused drugs : Dispose properly” - Effective “ collection and disposal” systems needed

Pharmaceuticals in the environment : Causes - Thousand of tons of pharmacologically active substances are used yearly to treat human and animal illnesses, in farming and aquaculture - These substances can be excreted unmetaboloised or as active metabolites, escape sewage treatment plants, enter the environment - Improper disposal of expired medications contribute to this contamination Issue : Contamination of sewage, surface, ground and drinking water

Pharmaceuticals in the environment : Consequences - Pharmaceuticals are designed to stimulate a response in humans and animals at low doses with a very specific target. - Pollution from pharmaceuticals is a complex phenomenon Thousand of different molecules,with different structures, characteristics and properties Differences amongst countries Frequent changes, new molecules .

Risk Management : Production Phase Audits - Waste Minimisation- BATNEEC , BPEO Issues ** The major environmental impacts from processes carried out by the pharmaceutical industry stem from the use of solvents as reaction media and as aids for separation and purification processes.  The solvents may be emitted directly into the atmosphere as VOCs (often as HAPs), or may appear in wastewater.  Sources of the latter include solvent residues from separative operations involving both a water and a solvent phase, as well as solvents captured in wet scrubbers. **  A Secondary impact from pharmaceutical operations is dusts generated by grinding and polishing operations.

Production Phase ( cont.) Issues List :- VOC emissions from :- Reactors Separation and purification processes Particulate emissions from grinding and polishing operations Solvent residues in wastewater from Two phase separations Wet scrubbers Solid wastes (often containing solvent residues) from extractive operations Quantitative impact data – USA , National Emmission Trends , 1996 tons/ year: Subsector VOC NOx HAP Medicinals And Botanicals 5,410 8,118 630 Pharmaceutical Preparations 7,997 6,558 4,287 Diagnostic Substances 20 17 18 Biological Products, Except Diagnostic 57 46 10   Total, pharmaceutical subsectors 13,484 14,739 4,945

Risk Management : Use Phase Major source of environmental impact ! Environmental risk reduction by reducing emissions into the environment Risk mitigation measures in the context of authorisation Instructions for safe handling and use Disposal of “ unused” pharmaceuticals Note – Specific Case of Cytotoxic Drugs

Effects on environment and human health needs to be investigated Example - Reported in Lancet, 2000 : “Italian Case Study for the Monitoring of Pharamceuticals in the Environment” by the Institute for Pharmacological Research,Milan

Conclusions Reported ----------------------------------------------- Pharmaceuticals selected :

Early this year the European Parliament proposed: “risk to the environment ” to be included in the risk / benefit assessment of new pharmaceutical drugs. - develop an environmental classification system for new pharmaceutical drugs eco-toxicological data on all new drugs “return-to-pharmacy” – label on all drugs

Public Purchasing Issue of eco-toxicological data in all purchasing of pharmaceuticals Results: environmental questioning should yield: - increased awareness among producers that the environmental problem of pharmaceutical drugs cannot be neglected - eco-toxicological data may in future be used for environmental classification of pharmaceuticals

How to manage substances in different use areas ? Same substances under different regulations

Different use areas of active substances - examples

Example : Environmental Relevance of NPEO NPEO leaves non ( very poorly ) degradable metabolite Nonylphenol in the environment NP is bioacumulative, high aquatic toxicity, inc. endocrine effects Within the EU Legislation ( 2001/838/EC ) : - Veterinary drugs : specific limits for PE containing teats - Pesticides & Biocides: Subtitution /phase-out of NPEO as active ingredient and co-formulant

Conclusion Seminar : Safe Disposal of Dangerous Pharmaceutical Waste Risk management should and can take place at all stages of life cycle Objectives of risk management is to reduce the environmental release and potential risks. Awareness raising for environmental problems linked with use of pharmaceuticals Conclusion